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PROMETHAZINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: COSETTE · Approved 2002-02-05

Drug application

FDA Application #

ANDA040428

Application type

Abbreviated New Drug Application (Generic)

Brand name

PROMETHAZINE HYDROCHLORIDE

Generic name

PROMETHAZINE HYDROCHLORIDE

Active ingredients

PROMETHAZINE HYDROCHLORIDE

Dosage form

SUPPOSITORY

Route

RECTAL

Marketing status

Prescription

Sponsor

COSETTE

Manufacturer

Cosette Pharmaceuticals, Inc.

First approval

2002-02-05

Source

Authoritative

Drugs@FDA application overview

Machine

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